Papilla Preservation Technique in Combination With Tooth Enamel Proteins and Animal Derived Bone Graft in Treating Isolated Bone Defects Between Teeth

Rungta College of Dental Sciences and Research

Status and phase: Completed; Phase 4

Conditions: Periodontal Diseases; Intrabony Periodontal Defect

Treatments: Procedure: Entire Papilla Preservation Technique; Procedure: Entire Papilla Preservation Surgical Technique (EPPT) alone and combined with enamel matrix derivative (EMD); Procedure: Entire Papilla Preservation Surgical Technique (EPPT) alone

Study type: Interventional

Funder types: Other

Identifiers

NCT07119307

RCDSR/IEC/MDS/2023/D-35

Details and patient eligibility

About

The present three-arm study compared the clinical and tomographic efficacy of the Entire Papilla Preservation Surgical Technique (EPPT) alone and combined with enamel matrix derivative (EMD) plus bone mineral derivedxenograph (BMDX), in the treatment of isolated, inter-dental intra-bony defects.

Full description

This randomized controlled clinical and tomographic study included 48 sites with isolated interdental intrabony defects, divided into three groups. Group 1 (control) received EPPT alone, Group 2 received EPPT with EMD, and Group 3 received EPPT with EMD and BMDX (Fix-Oss xenograft). Clinical parameters probing pocket depth (PPD), relative attachment level (RAL), gingival recession (GR), and papilla height-were recorded at baseline and 12 months. Cone-beam computed tomography (CBCT) was used to evaluate tomographic changes including defect width, CEJ-BD, CEJ-AC, X-ray INFRA and defect angle.

Enrollment: 58 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• stage II or III periodontitis, according to WWP 2017 classification of periodontal diseases in need of periodontal regenerative treatment for isolated intrabony defects
• single-rooted teeth/multi-rooted teeth without furcation involvement

Exclusion criteria

• uncontrolled or poorly controlled diabetes,
• unstable or life-threatening conditions, or requiring antibiotic prophylaxis,
• History of use of medications since last 6 months (immunosuppressants and antibiotics),
• Subjects allergic to medications,
• Pregnant or lactating women, Smokers/users of other tobacco products,
• Subjects showing unacceptable oral hygiene maintenance after initial phase I therapy and
• multiple interconnected vertical defects.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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58 participants in 3 patient groups, including a placebo group

Entire Papilla Preservation Technique

Placebo Comparator group

Description:

Entire Papilla Preservation Technique alone

Treatment:

Procedure: Entire Papilla Preservation Technique

Entire Papilla Preservation Technique with Emdogain

Active Comparator group

Description:

Entire Papilla Preservation Technique with Emdogain

Treatment:

Procedure: Entire Papilla Preservation Surgical Technique (EPPT) alone

Entire Papilla Preservation Technique with Emdogain and Bovine Derived Xenograft

Active Comparator group

Description:

Entire Papilla Preservation Technique with Emdogain and Bovine Derived Xenograft

Treatment:

Procedure: Entire Papilla Preservation Surgical Technique (EPPT) alone and combined with enamel matrix derivative (EMD)